Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice

Launched by BANNER LIFE SCIENCES LLC · Aug 3, 2023

Keywords

ClinConnect Summary

Monomethyl fumarate (MMF) is the active metabolite of the fumarate class of drugs used for the treatment of RRMS. Bafiertam is a formulation of MMF and does not require enzymatic conversion after oral administration. Adult participants with a diagnosis of RRMS who have been receiving continuous treatment with Bafiertam monotherapy per the approved product label for no more than 3 months (90 days) are eligible to enroll in the study. Their satisfaction with Bafiertam treatment will be assessed using a 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). To be included in the ...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or non-pregnant female aged 18 years and older.
• • 2. Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling.
• • 3. Participants may enroll if they are within 90 days of initiating therapy with Bafiertam.
• • 4. Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for the duration of the study.
• • 5. Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).
• • 6. Willing and able to complete all the study procedures and communicate meaningfully with study personnel.
• Exclusion Criteria:
• • 1. Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.
• • 2. Participated in another clinical trial within 30 days, suffered or still recovering from a medically significant event of surgery within 30 days, or previously participated in a clinical study with a similar investigational product.